Multivariate Method Based on Raman Spectroscopy for Quantification of Dipyrone in Oral Solutions

Autor(es)

Guimaraes, Luciana Lopes ; Moreira, Leticia Parada ; Lourenco, Barbara Faria ; Toma, Walber ; Zangaro, Renato Amaro ; Tavares Pacheco, Marcos Tadeu ; Silveira, Landulfo, Jr.

• Tipo de documento: Artigo Científico
• Fonte: JOURNAL OF SPECTROSCOPY; v. 2018, p. 10-pg., 2018-01-01.

Resumo

This work employed a quantitative model based on Raman spectroscopy and principal component regression (RS/PCR) to quantify the active ingredient dipyrone (metamizole) in commercially available formulations as an analytical methodology for quality control in the pharmaceutical industry. Raman spectra were collected using a dispersive Raman spectrometer (830 mn, 250 mW excitation, and 20 s exposure time) coupled to a Raman probe. Solutions of dipyrone diluted in water in the range of 80 to 120% of the concentration of commercial formulations (500 mg/mL) were used to develop a calibration model based on PCR to obtain the figures of merit for class I validation from the Brazilian Sanitary Surveillance Agency (ANVISA, RE no. 899/2003). This spectral model was then used to predict the concentration of dipyrone in commercial formulations from distinct brands with 500 mg/mL. A prediction error of 6.5 mg/mL (1.3%) was found for this PCR model using the diluted samples. Commercial formulations had predicted concentrations with a difference below 5.0% compared to the label concentration, indicating the applicability of Raman spectroscopy for quality control in the final product. (AU)

• Processo FAPESP: 09/01788-5 - Espectroscopia Raman dispersiva utilizando fibras ópticas "Raman probe" aplicada ao diagnóstico de neoplasias na pele e próstata
• Beneficiário: Landulfo Silveira Junior
• Modalidade de apoio: Auxílio à Pesquisa - Regular